Public Workshop Set on Drug Shortages
The Food and Drug Administration will host it from 8:30 a.m. to 4:30 p.m. Sept. 26 in Silver Spring, Md.
The Food and Drug Administration will host a public workshop Sept. 26 to review the current approach used by the agency's Center for Drug Evaluation and Research to address drug shortages, asking health care providers and others how to prevent or mitigate them.
The workshop will be held at 10903 New Hampshire Ave., Bldg. 31, room 1503 B and C (Great Room), Silver Spring, MD 20993. Information about special accommodations due to a disability, visitor parking, and transportation may be accessed at http://www.fda.gov/AdvisoryCommittees/default.htm under the heading "Resources for You."
"Given the increasing number of drug shortages and the attendant safety concerns for the public's health, it is important to discuss the causes of these shortages, as well as strategies to address them," FDA said in its meeting announcement, which said these topics will be discussed:
- How CDER becomes aware of drug shortages
- Reasons behind drug shortages
- Determination of medically necessary products
- Current good manufacturing practice and other compliance issues
- Actions taken when a drug shortage occurs
- Outcomes of mitigated drug shortages
- The public health impact of drug shortages and how to prevent them
As soon as a transcript is available, it will be posted at www.regulations.gov (Docket No. FDA-2011-N-0002).